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Cancer research

Development of a Solid Phase Extraction Cartridge-based Analytical Method for Cancer Gene Therapy

Strategic Insights

— 1 min read

Researchers from Mirati Therapeutics Inc. have developed a new method for testing active loading nanoliposome formulations using a solid phase extraction (SPE) cartridge. The method, which has been peer-reviewed, is designed to separate liposome-free drug from drug-loaded liposomes. The study found that the SPE method provided excellent detection linearity, acceptable limit of quantitation (LOQ), and satisfactory accuracy and recovery for free drug in spiked samples. A significant difference in free drug detection was observed among SPE, size exclusion chromatography (SEC), and HPLC-nanoparticle exclusion chromatography (HPLC-nPEC) methods for testing passive loading formulations.

Key Takeaways:

  • The newly developed SPE method was found to be reliable and efficient for testing active loading nanoliposome formulations.
  • The method provided excellent detection linearity (correlation coefficient ≥ 0.999) over a study concentration range of 1.0 to 46.9 μg/mL.
  • The LOQ for the SPE method was found to be 0.52 μg/mL, equivalent to 1.7% of free drug in a liposome formulation at 2.5 mg/mL.
  • The accuracy and recovery for free drug in spiked samples were within 90% to 94% for 4.5%, 9%, and 18% levels.
  • A significant difference in free drug detection was observed among SPE, SEC, and HPLC-nPEC methods for testing passive loading formulations.
  • The research was sponsored by Mirati Therapeutics, and the method was developed using HLB 3cc (60 mg) SPE cartridges.
  • The study concluded that the SPE method is a reliable and efficient way to determine free drug in nanoliposomal oncology drug formulations.

Statistics:

  • The correlation coefficient for SPE detection linearity was ≥ 0.999 over a study concentration range of 1.0 to 46.9 μg/mL.
  • The LOQ for the SPE method was 0.52 μg/mL, equivalent to 1.7% of free drug in a liposome formulation at 2.5 mg/mL.
  • The accuracy and recovery for free drug in spiked samples were within 90% to 94% for 4.5%, 9%, and 18% levels.

Sources:

  • Zhang, W. et al. (2025). Development of a Solid Phase Extraction Cartridge-based Analytical Method for Determination of Free Drug In Nanoliposomal Oncology Drug Formulations. Journal of Separation Science, 48(7).
  • Mirati Therapeutics Inc. (2025). Findings from Mirati Therapeutics Inc. Yields New Findings on Cancer Gene Therapy (Development of a Solid Phase Extraction Cartridge-based Analytical Method for Determination of Free Drug In Nanoliposomal Oncology Drug Formulations). Cancer Gene Therapy Week. July 21, 2025; p 44.

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